Glaxo Files Two Melanoma Drugs for U.S., Europe Approvals

By Makiko Kitamura -
Aug 3, 2012

GlaxoSmithKline Plc (GSK), the U.K.’s
largest drugmaker, said it submitted two experimental melanoma
medicines to regulators in the U.S. and Europe for approval
following trials that it deemed successful two months ago.

Glaxo filed dabrafenib with both the European Medicines
Agency and the U.S. Food and Drug Administration, the London-
based company said in a statement today. Glaxo is also applying
for U.S. approval of trametinib, and will seek European
clearance for trametinib in “coming months.”

The company said in June that about 80 percent of patients
with advanced melanoma given trametinib were alive after six
months, compared with 67 percent on chemotherapy, in a study it
funded. A separate study showed dabrafenib delayed disease
progression by 5.1 months, compared with 2.7 months for
chemotherapy, Glaxo said.

“These regulatory submissions represent important progress
in our oncology pipeline,” Rafael Amado, head of cancer
research and development at Glaxo, said in the statement.

Glaxo rose as much as 0.7 percent to 1,498 pence and was
trading up 0.4 percent at 11:06 a.m. in London. The stock has
gained 1.9 percent this year.

The drugmaker is also testing the two drugs in combination,
which may become the industry “gold standard” in treating
melanoma as early as 2014, according to Andrew Baum, a London-
based analyst at Citigroup Inc.

Dabrafenib works by blocking BRAF, a mutant gene that spurs
cancer-cell growth in about half of melanoma patients.
Trametinib is designed to thwart a related protein called MEK
that helps tumors resist an assault on BRAF.

Glaxo is studying the two-drug combination therapy with a
diagnostic test developed with France’s BioMerieux (BIM) to detect the
BRAF gene mutation. BioMerieux has filed the test for FDA pre-
market approval, Glaxo said today.

Estimated new cases of melanoma in the U.S. this year will
total 76,250, and the disease will cause 9,180 deaths, according
to the National Cancer Institute. While patients with early-
stage cancer respond well to treatment, the five-year survival
rate for those with melanoma that has spread is 15 percent,
according to the American Cancer Society.